Search Results
Found 33 results
510(k) Data Aggregation
K Number
K061758Device Name
ACTIVE RENIN IRMA
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
2006-07-28
(36 days)
Product Code
CIB
Regulation Number
862.1085Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K020945Device Name
AXSYM INTACT PTH, MODEL 2G06
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
2002-05-31
(67 days)
Product Code
CEW, JIT, JIX
Regulation Number
862.1545Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Device Description
AxSYM® I PTH is based on the Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM® I PTH assay uses paired monoclonal and polyclonal antibodies, each reactive with epitopes in the N-terminal portion of intact human PTH (1-84). The polyclonal antibody is biotin labeled. I PTH in the sample serves to bridge the two antibodies.
Ask a Question
K Number
K020128Device Name
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
2002-03-01
(45 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSL-10-8500 ACTIVE™ Free 3-hCG Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in serum. This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy.
Device Description
The DSL-10-8500 ACTIVE™ Free B-hCG ELISA kit was developed for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in human serum. The DSL ACTIVE® Free B-hCG ELISA is a two-site ELISA assay in which the free ß-hCG to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound Free B-hCG is directly proportional to the concentration of the Free ß-hCG present in the sample.
Ask a Question
K Number
K002128Device Name
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
2000-12-05
(144 days)
Product Code
NDR
Regulation Number
862.1260Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K001086Device Name
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
2000-05-18
(44 days)
Product Code
CDZ
Regulation Number
862.1680Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K990138Device Name
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
1999-06-21
(153 days)
Product Code
LOJ
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSL 10-8400 AFP ELISA assay is intended for the quantitative determination of AFP in human serum. It is intended for in vitro diagnostic use to aid in the management of patients with nonseminomatous testicular cancer.
Device Description
The DSL-10-8400 ACTIVE™ AFP ELISA is an enzymatically amplified "two-step" sandwichtype immunoassay. In the assay, Standards, Controls and unknown serum samples are incubated in microtitration wells which have been coated with anti-AFP antibody. After incubation and washing, the wells are treated with another anti-AFP detection antibody labelled with the enzyme horseradish peroxidase (HRP). After a second incubation and washing step, the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the degree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement at 450 and 620 nm.
The absorbance measured is directly proportional to the concentration of AFP present. A set of AFP Standards is used to plot a standard curve of absorbance versus AFP concentration from which the AFP concentrations in the unknowns can be calculated.
Ask a Question
K Number
K981871Device Name
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
1998-11-09
(165 days)
Product Code
DCK
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSL-10-42100 C-Reactive Protein (CRP) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.
Device Description
The DSL C-Reactive Protein (CRP) ELISA kit was developed for the quantitative measurement of CRP in human serum. The ELISA format is a capture assay. Rabbit anti-human polyclonal antibody against CRP is immobilized to the inner surface of the microtiter plate wells. CRP in the standards or serum samples is "sandwiched" between this antibody and the anti-CRP rabbit polyclonal antibody conjugated to horseradish peroxidase enzyme.
Ask a Question
K Number
K973243Device Name
ACTIVE PSA ELISA (DSL-10-9700)
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
1998-08-03
(339 days)
Product Code
LTJ
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
Device Description
The DSL 10-9700 PSA ELISA kit was developed for the quantitative measurement of Total PSA in human serum. The ELISA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the microtiter plate wells, the other antibody is conjugated the the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the microtiter plate. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
Ask a Question
K Number
K973244Device Name
ACTIVE PSA IRMA (DSL-9700)
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
1998-08-03
(339 days)
Product Code
LTJ
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
Device Description
The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
Ask a Question
K Number
K981607Device Name
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
Manufacturer
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
Date Cleared
1998-05-27
(22 days)
Product Code
CIB
Regulation Number
862.1085Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of active renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
Device Description
The DSL 25100 ACTIVE™ Renin Coated Tube IRMA Kit was developed for the quantitative measurement of active renin in human serum or plasma. This Coated Tube IRMA format is a capture assay. Anti-human renin mouse monoclonal antibody to renin is immobilized to the surface of the coated bead. Renin in the standards or samples is "sandwiched" between this monoclonal antibody and the anti-human Renin mouse monoclonal antibody radiolabeled for detection with I-125.
Ask a Question
Page 1 of 4